Deferred Treatment With Sofosbuvir-Velpatasvir-Voxilaprevir in Chronic HCV

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The most common adverse events were fatigue, headache, diarrhea, and nausea.
The most common adverse events were fatigue, headache, diarrhea, and nausea.

A once-daily combination tablet containing sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg) is highly effective in the treatment of patients with chronic hepatitis C virus (HCV) infection who previously did not respond to treatment with a nonstructural protein 5A (NS5A) inhibitor-containing regimen, according to a multicenter open-label deferred treatment substudy published in The Lancet Gastroenterology & Hepatology.

While direct-acting antiviral (DAA) regimens containing NS5A inhibitors are highly effective in the treatment of chronic HCV infection, prior to the approval of sofosbuvir-velpatasvir-voxilaprevir, no retreatment options were available for patients who did not respond to such treatment.

The POLARIS-1 study was the first phase 3 randomized placebo-controlled trial that demonstrated that 12 weeks of sofosbuvir-velpatasvir-voxilaprevir was highly effective in this population of patients with chronic HCV infection.

The researchers then conducted a substudy of POLARIS-1 in which 147 patients with HCV who were assigned to the placebo group in the primary study were subsequently treated with once-daily sofosbuvir-velpatasvir-voxilaprevir for 12 weeks to assess its efficacy and safety.

The researchers found that 143 patients (97%) achieved a sustained virologic response 12 weeks after the end of treatment (SVR12); 4 (3%) had virologic relapse, all of whom had HCV genotype 1a infection; and 1 patient had compensated cirrhosis. The most common adverse events were fatigue (21%), headache (20%), diarrhea (19%), and nausea (14%). No deaths, treatment discontinuations, or treatment-related serious adverse events occurred.

Thus, this substudy further supports the efficacy and safety of sofosbuvir-velpatasvir-voxilaprevir treatment and represents an important advance in patients with limited retreatment options as a salvage regimen.

“In summary, treatment with sofosbuvir-velpatasvir-voxilaprevir for 12 weeks was highly effective in [the] treatment of patients with chronic HCV genotype 1 infection who previously did not respond to treatment including an NS5A inhibitor,” stated the study investigators.

Reference

Bourlière M, Gordon SC, Schiff ER, et al. Deferred treatment with sofosbuvir–velpatasvir–voxilaprevir for patients with chronic hepatitis C virus who were previously treated with an NS5A inhibitor: an open-label substudy of POLARIS-1 [published online May 30, 2018]. Lancet Gastroenterol Hepatol. doi:10.1016/S2468-1253(18)30118-3

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